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4 new reference standards and 19 replacement batches released in February 2020

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Products and Services
News
04 March 2020
Strasbourg, France

Information for Indian users

Shipments to China

See also:

Content of the Ph. Eur. RS catalogue
How to place an RS order

 

The EDQM announces the availability of:

 

  • 4 new European Pharmacopoeia (Ph. Eur.) reference standards:

Catalogue code

Name

Unit quantity

Y0002180

Clomifene citrate for ID and assay

50 mg

Y0002159

Rhein CRS

25 mg

Y0002151

Senna Extract HRS

25 mg

Y0002143

Sennoside B CRS

15 mg

 

  • 19 replacement batches for Ph. Eur. reference standards:

Catalogue code

Name

Batch

Unit quantity

Y0000699

Paclitaxel impurity C CRS

3

10 mg

Y0001597

Diacerein impurity mixture CRS

2

0.014 mg

H1110000

Human tetanus immunoglobulin BRP

2

50 mg

Y0001906

Alfuzosin for system suitability A CRS

2

10 mg

Y0001460

Acetylsalicylic acid for peak identification CRS

5

10.3 mg

C2190000

Ciprofloxacin hydrochloride CRS

7

100 mg

Y0000393

Closantel for system suitability CRS

2

20 mg

P2152015

Pivmecillinam impurity C CRS

3

20 mg

Y0001206

Asiaticoside CRS

2

40 mg

Y0001321

Dermatan sulfate and over-sulfated chondroitin sulfate CRS

4

1 mL

Y0000336

Thiamazole CRS

2

30 mg

C0640000

Delta-3-Cefaclor CRS

5

15 mg

Y0001482

Hydrocortisone acetate for peak identification CRS

3

15 mg

K0600000

Ketoconazole CRS

3

150 mg

Y0001483

Saw palmetto extract HRS

2

8000 mg

Y0000635

Modafinil CRS

2

130 mg

Y0000094

Diosmin CRS

7

70 mg

Y0000650

Tamsulosin hydrochloride CRS

2

10 mg

Y0000105

Rutoside trihydrate CRS

4

100 mg


Information on reference standards removed from catalogue

None


Information on reference standards with a future removal from catalogue

  • 01/04/2020

Catalogue code

Name

Comments

F0230000

Fluocortolone pivalate CRS

 

N1080000

Nomegestrol acetate CRS

 

P2804000

Prednisolone hexanoate CRS

 

Y0000342

Testosterone for impurity D identification CRS

 

Y0000343

Testosterone for system suitability CRS

Replaced by Y0002174 Testosterone for system suitability A CRS

Y0000570

Clobetasol for peak identification CRS

 

Z2500010

Zolpidem impurity A CRS

 

 

  • 02/07/2021

Catalogue code

Name

Comments

C2332000

Clomifene citrate for performance test CRS

Removed from Ph. Eur. supplement 10.2 (in application from 01/07/2020) but kept on sales for an additional 6 months according to new policy (see “Change in the policy for withdrawing reference standards from sale”).

Y0001850

Oxytetracycline for system suitability CRS


Information on change of sales units

None


Information on change of EDQM storage/shipping conditions

In order to ensure better stability, storage and shipping conditions will be changed on 16/03/2020 for the following reference standard:

  • Beta-Ecdysterone CRS batch 1 will be stored at +5 °C and shipped at ambient temperature.

In order to ensure better stability, storage and shipping conditions have been changed for the following reference standard:

  • Enalapril impurity mixture A CRS batch 2 is now stored at –20 °C and shipped at +5°C.

Change in the policy for withdrawing reference standards from sale

A new policy will be applied from the application of Supplement 10.2 (01/07/2020). Detailed information is available in the news item of 24 January 2020.


Information for Indian users: shipment of Oxytocin CRS to India

The Ministry of Health and Family Welfare of India has lifted the ban on Oxytocin reference standards imported exclusively for the purpose of test and analysis.

The EDQM is therefore now in a position to ship Oxytocin CRS and Oxytocin/Desmopressin validation mixture CRS (catalogue code O0700000 and O0770000) to India again.


Shipment to China

Due to the coronavirus situation, the EDQM is experiencing issues in shipping Reference Standards to China. As the situation is changing rapidly, the EDQM will contact all concerned users to agree on the best possible course of action (see EDQM portal news of 12 February 2020).


Information on the current non-availability of a reference standard

Ph. Eur. Somatropin/Desamidosomatropin resolution mixture CRS (Y0000711) is currently unavailable.

In order to overcome the temporary shortage of this CRS and until the replacement batch is made available, it is advised to prepare the system suitability resolution solution for the test of related proteins described in the monographs 0950 (Somatropin concentrated solution), 0951 (Somatropin) and 0952 (Somatropin for injection) by using the Ph. Eur. Somatropin CRS Batch 3 (Cat. No. S0947000).

See more information in the Note to users.


Content of the European Pharmacopoeia RS catalogue

The EDQM proposes more than 3 000 Ph. Eur. RS including a wide range of highly-characterised chemical reference substances (CRS), herbal reference standards (HRS) and biological reference preparations (BRP), as well as reference spectra for the tests and assays to be carried out in accordance with the official methods prescribed in the Ph. Eur. The Ph. Eur. RS catalogue is updated on a daily basis and gives access not only to all the Ph. Eur. RS, but also to:

  • Batch Validity Statements (BVSs) for each reference standard;
  • Safety Data Sheets and Safety Data Statements for hazardous biologicals;
  • leaflets (downloadable PDF).

For your convenience, the Ph. Eur. RS catalogue is published on a daily basis and can be downloaded in PDF format and in XML format.


How to place an RS order

If you wish to place an order, you can send your request to the EDQM either:

  • via the web store (this form can also be used to confirm a proforma invoice or a quotation you have already received from the EDQM);
  • or by e-mail to orders@edqm.eu (in this case, please ensure that your order, on your company letterhead, states both the catalogue code and substance name and is attached to your e-mail).
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